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Mifepristone in North Carolina: Judge rules abortion drug can be taken at home

A North Carolina federal judge overruled a spate of new state laws that imposed new requirements on the use of Food and Drug Administration approved abortion pills.

The ruling means that pregnant people can again take the medicine mifepristone at home and can obtain the medication from a pharmacy or by mail. New North Carolina laws had required people to take the medicine only in the physical presence of a licensed physician.

Additionally, an in-person follow up visit is not required, though a requirement remains for people to have an in-person consultation 72 hours prior to taking the medicine. The lawsuit was brought by Dr. Amy Bryant, a UNC Health OB-GYN.

“Politicians in North Carolina cannot interfere with the FDA’s authority and impose medically unnecessary restrictions on medication abortion care,” Bryant said after the ruling.

The new laws were passed by the Republican-led state legislature. They mandated that only a licensed physician could provide the abortion drug mifepristone, that the medication had to be provided in person, that it required an in-person follow up visit, and required reporting of all adverse events — including those that are not fatal.

But these rules have already been considered and expressly rejected by the FDA. Therefore, Federal District Court Judge Catherine Eagles ruled that states cannot impose those specific added requirements.

“This case thus raises the question of whether and when a state can impose additional requirements on the distribution of an FDA-approved drug,” Eagles wrote in a previous filing. “While this case concerns the distribution of a drug used to terminate a pregnancy, a similar case could arise over any drug, from FDA-approved thyroid or diabetes medications, drugs for cancer treatment, vaccinations, contraceptives, or opioids for pain management.”

Eagles added in that same filing: “The Court finds and concludes that to the extent North Carolina law imposes safety restrictions on the distribution of the drug that the FDA has implemented and then later affirmatively rejected and removed, those laws frustrate the congressional goal of establishing a comprehensive regulatory framework under which the FDA determines conditions for safe drug distribution that do not create unnecessary burdens on the health care system or patient access.”

The new North Carolina laws also required an in-person consultation 72 hours prior to taking mifepristone. Because that had not specifically been considered by the FDA, that new requirement was allowed to stand.

Bryant filed the lawsuit against Josh Stein in his capacity as Attorney General. Stein, a Democrat running for governor, recused himself and legislative leaders Phil Berger and Tim Moore were allowed to join in to defend the laws. As of Tuesday afternoon, they had not indicated if they would appeal the ruling.

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